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The Medicines and Healthcare products Regulatory Agency (MHRA) has approved eplontersen (Wainzua) to treat adults with polyneuropathy associated with hereditary transthyretin amyloidosis (ATTRv), which is a rare progressive …
As with all products, the MHRA will keep its safety under close review.
In a UK-first, the Medicines and Healthcare products Regulatory Agency (MHRA) and Barts Health NHS Trust have developed a DNA sequencing approach that can be implemented onsite in hospitals so they can diagnose bacterial inf…
As with all products, the MHRA will keep its safety under close review
A study found that around 4 months after vaccination, people who received the RSV vaccine had a 79% reduction in their risk of getting lower respiratory tract disease caused by RSV, compared with those who received placebo.
This national approval was granted after an Access Consortium new active substance work-sharing initiative (NASWSI) procedure.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 14 February 2025, approved efanesoctocog alfa (brand name Altuvoct) to be used to treat and prevent bleeding in patients aged 2 years and above with s…
Gozetotide binds to the cancer cells with prostate-specific membrane antigen (PSMA) on their surface, making them visible during the PET scan.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 4 February 2025, approved the vaccine chikungunya vaccine (live) (brand name IXCHIQ) to protect adults against chikungunya disease, caused by the chik…
New guidance helps manufacturers navigate medical device regulations and protect users of digital mental health technologies.
It is the only example globally of an end-to-end access pathway, where a medicine developer can work collaboratively with the national health system, the regulator, and health technology assessment bodies from the early stag…
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 24 January 2025, approved garadacimab (brand name Andembry) for patients aged 12 years and older with hereditary angioedema (HAE) to prevent angioedem…
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the medicine aprocitentan (Jeraygo) to treat hypertension (high blood pressure) in adults whose blood pressure cannot be adequately controlled by at…
As with any medicine, the MHRA will keep the safety and effectiveness of seladelpar under close review.
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved (27 December 2024) the medicine sotatercept (Winrevair) to treat pulmonary arterial hypertension (PAH).
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 31 December 2024, approved the medicine tarlatamab (Imdylltra) to treat adult patients with small cell lung cancer (SCLC) that has spread throughout t…
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (20 December 2024) granted a conditional marketing authorisation for the medicine givinostat (Duvyzat) to treat Duchenne muscular dystrophy (DMD).
The Medicines and Healthcare products Regulatory Agency has approved the medicine delgocitinib (Anzupgo) to treat moderate to severe chronic hand eczema in adults when topical corticosteroids are inadequate or inappropriate.
With industry already showing a very high level of readiness, the MHRA is reminding remaining marketing authorisation holders to ensure they are prepared for the new packaging and labelling measures
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